PROFESSIONAL SUMMARY:

• Around 5.5 years of diversified experience in the Pharmaceutical and Medical Device Industries working as a Validation Analyst / Specialist focusing on Software, Laboratory Instruments and Equipment Validation
• Comprehensive knowledge related to 21 CFR Part 11: Electronic records, Electronic signatures and Audit trials
• Expertise in developing Installation, Operational and Performance Qualification ( IQ, OQ and PQ) Validation Protocols
• Extensive validating experience in FDA regulated environment and research laboratories with good understanding of GxP ( cGMP, GCP, GLP, cGAMP) standards
• Good knowledge of Laboratory Information Management Systems (LIMS), Electronic Database Management System ( EDMS) and Adverse Event Reporting System (AERS).
• Experience in documenting and reviewing all aspects of Computer System Validation (CSV) life cycle for quality assurance
• Proficient in Calibration and Validation of analytical & laboratory instruments like Mass Spectrometer, Chromatography (GC & HPLC), Spectrophotometers, Incubators and Fermentors
• Extensive experience developing Validation strategy, Validation master plans, Qualification plans, Standard Operating Procedures (SOP), User manuals and Validation scripts.
• Ability to multitask in a fast paced environment
• Possess solid researching skills, analytical thinking, problem solving skills and positive attitude

PROJECT HISTORY:

Confidential, Groton, CT

Validation Engineer / Technical Writer

• Involved in creating URS (User Requirement Specification), FS (Functional Specification) based on BPRS (Business Process Requirements Specifications) and PFD (Process Flow Diagram).
• Designed Use Case diagrams, Activity diagrams and Sequence diagrams to analyze the system using UML.
• Wrote Validation Master Plan, Validation Protocols (IQ, OQ, PQ), Traceability Matrix, Test Summary Report and Validation Summary Report.
• Performed system and functional risk analysis. Performed risk analysis for new modules as well as system changes to existing modules to expose all the risks associated with the requirements and to define testing required for mitigating those risks.
• Participated in the preparation of Standard Operation Procedures (SOPs).
• Drafted the Remediation Plan for the Project Management approval after Gap Analysis.
• Prepared and used the Requirement Traceability Matrix (RTM) to gauge the progress on a regular basis.
• Conducted JAD sessions and worked with the data modeler and database developer to create the logic of implementing LabWare LIMS V6.
• Responsible for pre and post formation review of Unit Test scripts, Performance /Automated Test Scripts, Regression Test Scripts, IQ/OQ/PQ Test Scripts.
• Helped and trained the remote team responsible for creating LoadRunner scripts, for performance/load testing of LIMS.
• Constantly communicated with business and developers to develop test cases for testing complex requirements and functionalities. Guided users in execution of test scripts.

Confidential, Walkersville, MD

Validation Analyst

• Ensured appropriate regulations, such as 21 CFR Part 11, 210/211and cGxP regulations are addressed in validation.
• Coordinated, assisted and documented validation activities; preparation/approval of protocols and reports.
• Prepared and assisted in system design, specification development, and design review.
• Performed FDA based customized systems validation for the intended use and environment of the system.
• Ensured Validation and Calibration of all laboratory equipment like GC, HPLC, Autoclaves, Ovens, Incubators, ICP Mass Spectrophotometer and wrote SOPs for calibration and maintenance of this equipment.
• Performed validation related activities like revalidation and change control.
• Assessed the impact of system changes through change management and change control systems; participated in the planning and implementation of change.
• Create validation documentation (GxP risk assessment, verification and validation plan, test scripts and IQ/OQ/PQ protocols, etc.) for the Risk Evaluation & Mitigation Strategy (REMS) project.
• Collaborated closely with the clients for activities and documentation related to Commissioning, Qualification and Validation (CQV) programs during start - up and commissioning of the related equipment and utilities
• Developed and maintained Validation and SOPs - forms, documentation and files.
• Coordinated meetings, document issues, action items, meeting notes, and perform appropriate follow up related to CSV projects.
• Provided training to colleagues and contractors on our approach to systems implementation and SOP’s.

Confidential, Wayne, PA

Validation Analyst

• Developed strategies to improvise good validation and contribute to every phase of the Validation life cycle (VLC)
• Prepared a Test schedule in order to maintain optimal work flow
• Provided technical support during software installation
• Used HP Quality Center to efficiently draft Test Plan and Test Scripts and keep a track of software deviations
• Earned extensive experience building test cases, test procedures and test reports.
• Analyzed test results to ensure existing functionality performs as specified and recommended corrective actions.
• Carried out functional testing, reviewed test case results in order to check against user requirement specifications in the specified time period
• Carried out Gap Analysis, identified deviations that occurred during validation, prepared Deviation Handling reports, ensured GxP compliance
• Carried out Risk Assessment as a part of the project risk management plan
• Interacted with the project manager, validation manager, as well as the QA team in order to ensure project conformity, participated in Project meetings and reviews.
• Coordinated the tasks with different teams, and team members in order to achieve the results within the set timeline
• Initiate Incident Reports, Initiate Investigation and Change Controls Reports

Confidential, San Antonio, TX

Quality Engineer

• Reviewed and approved investigations of returned products and/or related reports according to current Good Manufacturing Practices (cGMP)
• Auditing of vendors/subcontractors for Quality Systems and Procedures
• Participated in identification of active chemical residues and wrote cleaning validation procedure to ensure clean equipment for every batch.
• Reviewed and approved non-conformances and planned deviations of Recommended CAPAs to address non-conformities and deviations
• Worked with Engineering groups to ensure testing as required on product investigations
• Analyzed data using Minitab for developing statistical process controls and involved in Quality Management Systems (QMS) documentation and maintenance.
• Wrote SOPs and cleaning validation procedures for process and laboratory equipment, electro-optic&online process control instrumentation (measurement systems) and CNC equipment
• Proposed and implemented extensive documentation for validation life cycle which included validation protocols, IQs, OQs and PQs
• Involved in performing GAP analysis, preparing Remediation Plans and made incident reports
• Verified Manufacturing, QC and Laboratory Procedures against the Worldwide Guidelines and Policies